Status:
COMPLETED
Feasibility Study of Cryotherapy for Chronic Venous Disorders
Lead Sponsor:
Medical University of South Carolina
Conditions:
Venous Insufficiency
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized and under-treat...
Detailed Description
Chronic venous disorders (CVDs) often cause long-term disability for those who experience the worst manifestations of CVDs: disabling pain and non-healing leg ulcers. Such disabilities have significan...
Eligibility Criteria
Inclusion
- Aged 45 years and older
- CEAP classification: stage C4 (changes in skin and subcutaneous tissue secondary to CVDs)4a (pigmentation or eczema) 4b (lipodermatosclerosis or atrophie blanche) C5 (healed venous ulcers)
- Ankle brachial index (ABI) 0.9 - 1.3mm Hg 0 absence of peripheral arterial disease
- Intact skin sensation measured with 10 gram monofilament
- Intact thermal sensation measured with thermal sensory tester at lower leg skin and foot surfaces
- Agreement to wear compression garments such as wraps or stockings during waking hours
- Phone, e-mail, or mail accessible
- Working freezer
Exclusion
- ABI \< 0.8 mm Hg or \> 1.3 mm Hg -presence of lower extremity arterial disease (reduces skin temperature)
- Active systemic or localized infections such as cellulitis (raises skin temperature)
- Autoimmune disorders that reduce blood flow such as Raynaud's phenomenon
- Body temperature \> 37.6 degrees C (febrile state raises skin temperature)
- CEAP classification c6: active venous ulcer (cooling ulcerated skin might impair healing)
- Known peroneal nerve injury
- Impaired skin sensation
- Unable to detect light touch measured with a 10 gram monofilament at lower leg skin surfaces
- Unable to detect not/cold sensation measured with thermal sensory tester at lower leg skin surfaces
- Not wearing compression or not agreeing to wear compression wraps or stockings
- Phone, e-mail, or mail inaccessible
- No working freezer
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
End Date :
August 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00617825
Start Date
September 1 2007
End Date
August 1 2009
Last Update
June 15 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-1600